FDA Approves Wider Use of Tarceva

19 April 2010 (Last Updated April 19th, 2010 18:30)

The US FDA has approved the wider use of OSI Pharmaceutical's Tarceva, a once-a-day pill to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The drug is now available as a broader population treatment as a first maintenance treatment suitable for pa

The US FDA has approved the wider use of OSI Pharmaceutical's Tarceva, a once-a-day pill to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The drug is now available as a broader population treatment as a first maintenance treatment suitable for patients with locally advanced or metastatic NSCLC whose disease has not advanced after four cycles of platinum-based chemotherapy.

Tarceva has already been approved by the FDA for patients with advanced NSCLC whose cancer has grown or spread after receiving at least one course of chemotherapy.

OSI is evaluating additional uses for Tarceva, such as the treatment for lung cancer patients with an activating EGFR mutation, adjuvant therapy in NSCLC and in other tumour types such as hepatocellular carcinoma ovarian cancer.

OSI is currently considering a takeover bid from Japanese drug-maker Astellas Pharma, which said there will be no plans to raise its bid for OSI despite the wider approval of Tarceva.

Astellas launched a hostile takeover bid for OSI, the deadline for which has been extended to 23 April, at $52 per share tender offer, which would total a bid of $3.5bn.